Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

3.2.P.1

Description and Composition of the Drug Product – Max Strength Cold & Flu Day & Night Capsules The pack as proposed for marketing is a combination pack and contains 12 Day capsules and 4 Night capsules. The Day capsules are the subject of another UK MA application as Max Strength Cold and Flu Capsules – PL 12063/0066 granted 9 June 2006. The Night capsules are also the subject of another UK MA application as Max Strength Night Time Capsules – PL 12063/0072, currently pending.

• Description of the dosage form Day Capsules

Red capped, yellow bodied hard gelatin capsules containing the component drug product, an off-white powder, containing Paracetamol, Caffeine and Phenylephrine Hydrochloride. Night Capsules Dark blue capped, translucent light blue bodied hard gelatin capsules containing the component drug product, an off-white powder, containing Paracetamol and Phenylephrine Hydrochloride.